Core Insights - Oncocyte Corp. has announced a positive update regarding the pricing of its next-generation lab-developed test (LDT), GraftAssureCore, which enhances its position in the transplant rejection testing market and indicates potential growth in its estimated $1 billion total addressable market [1][6] Pricing and Reimbursement - The Centers for Medicare & Medicaid Services (CMS) has increased the reimbursement rate for GraftAssureCore to $2,753 per result, up from $2,222 for first-time testing and $1,029 for subsequent tests [2] - This new pricing aligns with existing competitive technologies and expands market appeal for future FDA-cleared kitted products at transplant centers [6] Company Strategy and Future Prospects - Oncocyte has invested significantly in improving the scalability and manufacturability of its workflow, which supports its kitted test program [3] - The new reimbursement rate establishes a benchmark for future kitted tests, such as GraftAssureDx, which is expected to be submitted for FDA review by the end of the year [3] - The company anticipates that receiving FDA authorization will enable broader adoption of its technology, allowing transplant centers to access high-quality, FDA-cleared kits with established reimbursement [4] Clinical Trials and Market Engagement - Oncocyte has received approval from a Central Institutional Review Board for its clinical trial, with final preparations underway at participating transplant centers [4] - The company expects participation from three of the top 10 U.S. transplant centers, representing nearly 10% of annual U.S. transplant volume [4] Technology and Market Position - Oncocyte's technology quantifies donor-derived cell-free DNA (dd-cfDNA), which has been established as a trusted biomarker for transplant rejection [5] - The company is rebranding its test portfolio under the GraftAssure brand, with GraftAssureCore being the new name for its previously marketed VitaGraft assay [5]

Core Viewpoint - Oncocyte Corp. is making significant progress towards initiating a clinical trial for an organ transplant rejection monitoring test kit, which is essential for obtaining regulatory authorization to market the product [1][6]. Company Progress - Oncocyte has completed the clinical trial design and received approval from a central institutional review board (IRB) [2]. - The company expects to include three of the top 10 transplant centers in the U.S. as participants in the clinical trial, representing nearly 10% of the U.S. transplanted organ volume [3]. - Oncocyte estimates that transplant rejection testing generates approximately $500 million in annual revenue in the U.S., with a global addressable market exceeding $1 billion [4]. Market Engagement - The transplant community is enthusiastic about the opportunity to conduct testing in-house, with major transplant centers supporting Oncocyte's efforts [5]. - Oncocyte plans to announce its National Principal Investigator (NPI) soon and will host a conference call to introduce this key opinion leader [5]. Regulatory Pathway - The upcoming clinical trial is the only requirement for FDA authorization of Oncocyte's test kit, which is being pursued through a Class II de novo pathway [6]. - Oncocyte is preparing for its second and final Q-Submission (Q-Sub) meeting with the FDA, following productive discussions in previous meetings [7][8].